CN101245157B - Film-forming agent composition and starchiness vegetable adhesive containing the composition - Google Patents
Film-forming agent composition and starchiness vegetable adhesive containing the composition Download PDFInfo
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- CN101245157B CN101245157B CN2007100799230A CN200710079923A CN101245157B CN 101245157 B CN101245157 B CN 101245157B CN 2007100799230 A CN2007100799230 A CN 2007100799230A CN 200710079923 A CN200710079923 A CN 200710079923A CN 101245157 B CN101245157 B CN 101245157B
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Abstract
The invention provides a film forming compound with modified starch as the main component, a film forming material containing the compound, and more particularly a hard-shell natural capsule made from the compound. The compound contains no or very little animal protein such as gelatin, etc. The compound can partially or completely replace the gelatin from animals for producing natural hard-shell capsules. The prepared natural capsule shell product has the advantages of excellent film forming property, high strength, good flexibility, high transparency, decomposability and microbial pollution resistance. The main component of the compound, modified starch, has stable quality and highly controllable performance.
Description
Technical field
The present invention relates to a kind of is membrane-forming agent composition main component, that do not contain or only contain a small amount of gelatin with the modified starch, its preparation method and the film-forming properties material, particularly hard-shell capsule made with said composition.Therefore the film-forming properties material source made from material of the present invention and method also can be referred to as " starchy plant glue " in vegetable material, and it has and similar character of the gelatine capsule of animal-origin and application, is specially adapted to make hard-shell capsule.
Background technology
In the nearly centenary time, hard gelatin capsule is the popular formulation that is applicable to prescription and nonprescription drugs.Medicinal hard gelatin capsule is a domestic and international pharmaceutical manufacturer medicine formulation commonly used always.The consumer preference capsule is because capsule has the benefit of being convenient to swallow.
Normally a kind of oblong solid cryptomere formulation of capsule.Generally speaking, use automatic machine equipment can make empty hard gelatin capsule.
This equipment comprises the stainless steel needle that is installed on rod or the plate in a row, and these stainless steel needles are immersed in to be kept in homogenization temperature and the mobile gelatin solution.Then these pins are extracted out from gelatin solution, rotation is inserted in the drying oven then, feeds the high wind of the filtrated air of humidity-controlled system in this drying oven.During drying, on every pin, just formed the crude product of 1/2nd capsule shell.Then each 1/2nd capsule shell is peeled and, be trimmed to the length of homogeneous, with in addition suitable match second half combine.
The material of above-mentioned hard rubber softgel shell or soft balsam softgel shell (hereinafter to be referred as the capsule material) all is made up of gelatin, glycerine, water and other medicinal materials, but each components in proportions is not quite similar, and the preparation method is also different.
Usually, the composition of empty hard gelatin capsule is: gelatin, softening agent (increasing toughness and plasticity-), thickening material (reduce flowability, increase jelly power), opalizer (photosensitive medicine) and other medicinal preparations auxiliary material such as sanitas or pigment etc.
As capsule material, gelatin exists certain shortcoming and limitation, may descend owing to the crosslinked solubleness that makes of gelatin after long-term insulation stores; In operating process, the solution of gelatin can be polluted by bacterial micro-organism.The basal component of conventional capsules softgel shell is gelatin, G ﹠ W.Gelatin is made through hydrolysis by bone, the skin of animal, belongs to protein matter, is widely used in pharmacy field.Softening in view of the easy dehydration of gelatine capsule sclerosis, suction, meet aldehyde material cross-linking and curing reaction easily take place, therefore should not the easy moisture absorption of filling, easy-weathering and the content that reacts with the capsule material material etc. of aldehyde radical (as contain).Particularly sweep across " mad cow disease " in Europe in recent years, traditional gelatine capsule agent market was also once impacted.People have carried out the hard-shell capsule that various effort manufacturings do not contain gelatin, but its shortcoming lacks enough tensile strength, elasticity, hardness and thickness often, do not have enough hardness to keep its shape and slickness in the course of processing.In addition, a lot of non-gelatin compositions shortages are kept the necessary mobility character of homodisperse in whole dip-coating process.Though people have carried out the rheological property that multiple effort improves these compositions, as increasing solids content wherein in order to increase its viscosity,, it is hard that such composition the surface occurs through regular meeting, and gloss descends and defective in uneven thickness.
Need find a kind of material, make its hard-shell capsule of making the same with the duricrust gelatine capsule glossy, very smooth, liked by the human consumer, but do not have the limitation of gelatin.
The inventor is devoted to the research that using denaturated starch prepares hard-shell capsule.Wherein said modified starch is through secondary processing, has changed the starch of character.
In order to adapt to various industrial application requirements.As: high-temperature technology (sterilization of canned food) requires starch high temperature viscosity good stability, and frozen product requires starch freeze thawing good stability, and jelly foodstuff requires that the transparency is good, good film-forming property etc.And in order to open up the new purposes of starch, broadened application scope.As: the starch that textile industry is used; The hydroxyethylamyle, the hydroxypropylated starch that replace blood plasma; Replace surgical glove with talcous high cross-linking starch etc., must carry out modification starch.The method of modification is normally utilized physics, chemistry or enzymatic treatment, on starch molecule, introduce new functional group or change starch molecule size and starch granules character, thereby change the natural characteristic (as: gelatinization point, thermoviscosity and stability thereof, freeze-thaw stability, gel force, film-forming properties, the transparency etc.) of starch, make it be more suitable for requirement in certain application.
According to the difference of processing mode, modified starch can be divided into physically denatured starch, chemically modified starch, enzyme process modified starch or composite modified starch.Its main kind has:
(1) physically denatured starch: handle the modified starch that obtains with various physical methods, for example starch, wet heat treatment starch, extruding modified starch or grease modified starch etc. are handled in pre-gelatinized starch, gamma-rays, ultra-high frequency radiotreatment starch, mechanical mill;
(2) chemically modified starch: handle the modified starch that obtains with various chemical reagent, two big classes are wherein arranged: a class is to make the decline of starch molecule amount, as acidified starch, Sumstar 190 or bake dextrin etc.; Another kind of is that the starch molecule amount is increased, as cross-linking starch, esterification starch, etherification starch or graft copolymerization starch etc.;
(3) enzyme process modified starch: various starch through microbiological treatment such as enzymes, as α, β, cyclooctaamylose, maltodextrin or resistant starch etc.;
(4) composite modified starch: the modified starch that adopts two kinds and above treatment process to obtain, as oxidative crosslinked starch, cross-linked esterification starch etc.
At present, modified starch is applied to textile industry (as warp size), building industry (as being used to make the plasterboard that no mortar wall construction is used), foodstuffs industry (as being used to make chewy gum) and paper industry (as Surface Size) more, wherein based on paper industry.
The patent application CN200310112803.8 of Southern Yangtze University and CN200510094853.7 disclose the application as the capsule material when the preparation microcapsule of the preparation method of acidolysis and the composite modified modified starch of esterification and described modified starch, but the report that modified starch is prepared hard-shell capsule as the capsule material is never arranged.
The inventor is through concentrating on studies, and discovery can modified starch be the capsule material of the film-forming composition of main component as manufacturing film-forming properties material, particularly hard-shell capsule, can prepare hard-shell capsule by all or part of replacement gelatin, thereby finish the present invention.
Summary of the invention
The purpose of this invention is to provide a kind of with the modified starch be main component, do not contain gelatin or the lower film-forming composition of gelatine content, said composition can be used for preparing film forming colloidal materials and goods thereof, described colloidal materials does not contain gelatin, or only contain a small amount of gelatin, be that a kind of novel starchy plant glue, the particularly present composition are best suited for the preparation hard-shell capsule.
Film-forming composition of the present invention is the film-forming composition that is used to prepare hard-shell capsule, wherein contains membrane-forming agent, thickening material and softening agent, and the main component that it is characterized in that wherein said membrane-forming agent is a modified starch.
Concrete, the membrane-forming agent that is contained in the film-forming composition of the present invention is a modified starch, the wherein also optional gelatin that contains.Therefore, described membrane-forming agent can be a modified starch, or the mixture of modified starch and gelatin.
In this film-forming composition, the content of membrane-forming agent approximately is the 80%-90% of composition total weight, and the content of thickening material and softening agent is the 10-20% of gross weight.
In this film-forming composition, in the gross weight of composition, the content of modified starch is 50.0-90.0%; The content of gelatin is 0-30.0%, and the content of preferred modified starch is 70.0-90.0%; The content of gelatin is 0-10.0%.
Do not contain gelatin in the membrane-forming agent composition of the present invention, or for traditional gelatine capsule, the content of gelatin is lower in the said composition, preferred gelatine content is not higher than 10%.
In actual production, in order to reduce cost, the modified starch in the present composition can also have a small amount of starch in replace of using, and in the case, the add-on of starch should be principle with the film forming properties needs that can satisfy product.
Use the gelatin composition in the modified starch replacement conventional capsules in the present composition, can all replace, or part is replaced by modified starch with modified starch.Employed modified starch can be various known modified starches in the said composition, with regard to the denaturation method of modified starch, starch of preferably crosslinked, esterification, oxidation, etherificate etc., the starch of preferred especially etherificate sex change, also can be the starch of taking multiple denaturation method sex change, as esterification Sumstar 190 etc.Preferred Sumstar 190, cross-linking starch, etherification starch, acidifying starch or esterification starch, more preferably oxidative esterification starch, for example potato oxidative esterification modified starch.
With regard to the source of starch, can use the starch that derives from each kind of plant.As W-Gum, tapioca (flour), melon starch, sago starch, wheat starch, yam starch etc.Preferred yam starch, tapioca (flour) and sago starch.With regard to starch structure, amylopectin is better than amylose starch, preferred pure amylopectin, i.e. waxy starch, particularly potato waxy starch and corn waxy starch.
Employed in the present composition, the term " starch " that does not add any modification is meant general starch, and its source and performance are had no particular limits.With regard to the source of starch, can use the starch that derives from each kind of plant, as W-Gum, tapioca (flour), melon starch, sago starch, wheat starch, yam starch etc., preferred yam starch.With regard to starch structure, preferred pure amylopectin, i.e. waxy starch, particularly potato waxy starch and corn waxy starch.
Employed thickening material can be pharmaceutical field and field of food thickening material commonly used in the present composition, particularly employed thickening material, for example cellulose family, carrageenin, gum arabic, seaweed gel class, xanthan gum, gelling gum, agar, protein powder, sucrose or the like when making gelatine capsule.
Employed softening agent can be pharmaceutical field and field of food softening agent commonly used, particularly employed softening agent, for example sorbyl alcohol, glycerine, pulullan polysaccharide, N.F,USP MANNITOL etc. when making gelatine capsule in the present composition.
That can also choose wantonly in the present composition contains other ancillary component, pigment for example, and preferred food dye, to make the film forming material of required tone, hard rubber softgel shell particularly; And for example sucrose fatty ester, stearin, phosphatide, tween, Vinlub, rosin glyceride, sapn emulsifying agents such as (Si Pan), the preferably sucrose fatty acid ester is with the consistency of the various materials of further raising.
It is application main component, that do not contain the lower film-forming composition of gelatin or gelatine content with the modified starch with the present invention that another object of the present invention provides a kind of, said composition can be used as starchy plant glue and uses, be used to prepare various film forming colloidal materials and goods thereof, the for example carrier of the wall material of microcapsule, essence and flavoring agent, food fresh keeping coating etc. are especially for the preparation hard-shell capsule.
In this article, hard or hard-shell capsule are meant a kind of hard housing compartment that administration component or effective constituent can be sealed.Here said " hard " is meant that this capsule has the ability of impact resistance modification.Hard commonly used or hard-shell capsule normally prepare as gelatin with animal material.Not containing gelatin with the hard of film-forming composition preparation of the present invention or the colloidal materials of hard-shell capsule, or only contain a small amount of gelatin, is a kind of novel plant gelatin capsules, has and similar character of the gelatine capsule of animal-origin and better safety in utilization.
Another object of the present invention has provided the method that a kind of usefulness film-forming composition of the present invention manufactures mould material, and this method comprises:
(1) weight ratio that composition of the present invention and water is mixed into said composition is about 10%～40%, preferred 25～35% homogeneous latex emulsion, and with 100 ℃-170 ℃, this emulsion of preferred 125～140 ℃ steam heating; Insulation is placed in the scope of room temperature to 90 ℃ then, obtains the film forming material of high-clarity;
(2) use can the definite shape moulding the film forming material of mechanical means manufacturing with definite shape.
Wherein said step (2) can be carried out on described equipment independently, also can carry out on the object of the described film forming material protection of needs.
The composition of the various reaction conditionss described in the aforesaid method and composition, relevant to the type of film forming material performance demands and prepared film forming material.For example, for the preparation hard-shell capsule, the optimal temperature that insulation is placed is 50-90 ℃, and when making was filmed, the temperature that insulation is placed should be lower, suits preferably to carry out in room temperature in the scope of room temperature to 50 ℃.
The film forming material for preparing with aforesaid method is diversified, for example can be the carrier, food fresh keeping coating etc. of wall material, the essence and flavoring agent of hard or hard-shell capsule, microcapsule, preferred hard-shell capsule.
Therefore, the method that also provides a kind of usefulness film-forming composition of the present invention to make hard or hard-shell capsule of the present invention, this method comprises:
(1) weight ratio that composition of the present invention and water is mixed into said composition is about 10%～40% homogeneous latex emulsion, with this emulsion of steam heating of 100 ℃-170 ℃; Place 50-90 ℃ of insulation then, obtain the film forming material of high-clarity;
(2) use automatic machine equipment and the above-mentioned film forming material of making hard or hard-shell capsule, make the hard rubber softgel shell according to the method for routine.
Concrete, the method that manufactures mould material and/or hard or hard-shell capsule with film-forming composition of the present invention may further comprise the steps:
(1) weight ratio that composition of the present invention and water is mixed into said composition is about 10%～40%, preferred 25～35% homogeneous latex emulsion, with 100 ℃-170 ℃, this emulsion of preferred 125～140 ℃ steam heating, time approximately is 20-40 minute, is generally about 30 minutes; Place 50-90 ℃ of insulation then, it is stable that the viscosity of this thickener kept in 24 hours, obtains the film forming material of high-clarity;
(2) use automatic machine equipment and the above-mentioned film forming material of making hard or hard-shell capsule, make the hard rubber softgel shell according to the method for routine.
Present composition most important applications is to be used to make hard capsules, described capsule can be widely used as wrapping material, in particular as the container that contains predetermined dose, can be used for fields such as medicine, food, makeup, chemical industry, as the wrapping material of medicine, food, healthcare products, makeup etc.This capsule is the duricrust plant capsule, and therefore its raw material sources have better safety in utilization in plant.
Compare with corresponding hard gelatine capsule, smooth and glossy the same of capsule of the present invention with the duricrust gelatin, the breakage rate when making capsule is low, but in the use not and the gelatin limitations associated.Because the plant capsule of modified starch matter can be promoted albumen, fat and carbohydrate absorption digestion, capsule shell of the present invention has the advantage that is better than traditional gelatine capsule shell:
1, low water content.The capsular water content of the present invention is lower than the conventional water content of gelatine capsule 12.5-17.5%, is generally 8%～12%, and it is strong and to the filling of the medicine or the functional food of water sensitive to be fit to very much water absorbability.As Chinese medical extract, have stronger water absorbability, easily absorb the moisture in the gelatine capsule, cause capsule 's content caking, softgel shell hardening, become fragile, quality problems such as disintegration or dissolution rate are defective.Because water content is low than gelatine capsule in the glue shell of the present invention, its outward appearance and dissolution rate are insensitive to moisture in the softgel shell and ambient moisture variation, and quality product is more easy to control.
2, suitability is wide, and no crosslinking reaction risk does not have interaction, and stability is high.The starch based derivative, amino acid whose crosslinking reaction risk in the gelatin-free (easily causing disintegration or stripping to reduce after crosslinked), drug release rate is more stable relatively, and individual difference is less.
3, storage requirement requires low.Be difficult for crisp brokenly in the low-humidity environment, high temperatures is good.Easily dehydration sclerosis or crisp broken under high temperature and low humidity condition of gelatine capsule storage environment is had higher requirement, and period of storage has more significantly influence to the gelatine capsule shell quality.
4, the antimicrobial contaminative of this plant capsule is greater than gelatine capsule.Because gelatin is a proteinaceous substances, is the substratum of bacterium.Many bacteriums such as anerobe, fungi etc. can both liquefy gelatins.By comparison, the capsule of preparation of compositions of the present invention has better antimicrobial pollution and degradation property.Even the capsule of present composition preparation stores under greater than 65% condition in atmospheric moisture, also be difficult for being degraded by microorganisms.
5, this vegetable jelly softgel shell plant amylum raw material that has drawn from, source safe.Be different from gelatine capsule shell and derive from the animal body that to suffer from disease.
Embodiment
In order further to set forth related material and the technology of technical scheme of the present invention, provided following embodiment.But the scope that these embodiment do not limit the present invention in any way.
Embodiment 1 gelatin composition is by the hard-shell capsule of replacing whole
The composition of present embodiment membrane-forming agent composition:
Component quantity (gram)
Potato cross-linking modified potato starch 150
Waxy corn cross-linking starch 150
Sorbyl alcohol 30
Carrageenin 3
Sucrose fatty ester 1
Food dye is an amount of
The method for preparing hard-shell capsule:
300 gram modified starches and 30 gram sorbyl alcohols and the carrageenins that weigh up, sucrose fatty ester etc. are mixed, add 700 again to restrain water, stir, with this emulsion of 130 ℃ of steam heating about 30 minutes; Obtain the film forming material of high-clarity, cool to 60 ℃ of insulations and place stand-byly, use automatic machine equipment and this material of making hard gelatin capsule to make about 5000 of hard-shell capsule.
Embodiment 2 gelatin compositions are by part alternate hard-shell capsule
The composition of present embodiment membrane-forming agent composition:
Component quantity (gram)
Potato acidifying etherificate modified starch 250
Gelatin 20
Sorbyl alcohol 30
Carrageenin 3.5
Sucrose fatty ester 0.8
Food dye is an amount of
Prepare about 5000 capsules according to method similar to Example 1.
Embodiment 3 gelatin compositions are by the hard-shell capsule of replacing whole
The composition of present embodiment membrane-forming agent composition:
Component quantity (gram)
Potato oxidative esterification modified starch 200
Waxy corn cross-linking starch 80
Sorbyl alcohol 30
Carrageenin 5
Sucrose fatty ester 1
Food dye is an amount of
Prepare about 5000 capsules according to method similar to Example 1.
Embodiment 4 gelatin compositions are by the hard-shell capsule of replacing whole
The composition of present embodiment membrane-forming agent composition:
Component quantity (gram)
Potato oxidative esterification modified starch 250
Waxy corn starch 50
Sorbyl alcohol 27
Carrageenin 5
Sucrose fatty ester 1
Food dye is an amount of
Prepare about 5000 capsules according to method similar to Example 1.
The coating antistaling agent of embodiment 5 fruits, food
The composition of present embodiment membrane-forming agent composition:
Component quantity (gram)
Potato acidifying etherificate modified starch 280
Waxy corn cross-linking starch 20
Glycerine 27
The carrageenin trace
The making method of filming:
Modified starch, glycerine and the carrageenin of above quantity are mixed, add 1500 gram water again and mix, with this emulsion of 135 ℃ of steam heating about 30 minutes; Obtain the film forming material of high-clarity, cool to room temperature and place stand-by.With atomizer film forming material is sprayed onto fruit or food surfaces, after doing through the low-grade fever wind, forms the glossy top coat.
With filming of method for preparing, particularly, not only can improve its outward appearance significantly, and can improve the keeping quality of volatility food ingredient widely as the wrapping material of fruit and varieties of food items as wrapping material.
Below described embodiment of the present invention in detail, can do a lot of improvement and variation obviously for a person skilled in the art and can not deviate from essence spirit of the present invention.All these changes and improvements are all within protection scope of the present invention.
Claims (13)
1. a film-forming composition wherein contains membrane-forming agent, thickening material and softening agent, and in the gross weight of composition, the content of described membrane-forming agent is the 80%-90% of composition total weight, and the content of thickening material and softening agent is the 10-20% of gross weight; In described membrane-forming agent, contain the modified starch of 50.0-90.0% and the gelatin of 0-30.0%; Wherein said modified starch is a potato oxidative esterification modified starch.
2. according to the described film-forming composition of claim 1, wherein said thickening material is selected from least a or any two kinds or the multiple mixture in cellulose family, carrageenin, gum arabic, seaweed gel class, xanthan gum, gelling gum, agar, protein powder and the sucrose.
3. according to the described film-forming composition of claim 2, wherein said softening agent is selected from least a or any two kinds or the multiple mixture in sorbyl alcohol, glycerine, pulullan polysaccharide, the N.F,USP MANNITOL.
4. according to any described film-forming composition of claim 1-3, wherein in the gross weight of composition, the content of modified starch is 70.0-90.0% in the described membrane-forming agent; The content of gelatin is 0-10.0%.
5. according to the described film-forming composition of claim 4, also contain other auxiliary material in the wherein said film-forming composition, described auxiliary material is emulsifying agent or pigment.
6. according to the described film-forming composition of claim 5, wherein said emulsifying agent is a kind of or any two kinds or the multiple mixture in sucrose fatty ester, stearin, phosphatide, tween, Vinlub, rosin glyceride and the sapn.
7. according to the described film-forming composition of claim 5, wherein said pigment is a food dye.
8. according to of the application of any described film-forming composition of claim 1-7 as starchy plant glue.
9. according to the described application of claim 8, described film-forming composition is used to prepare hard-shell capsule.
10. according to the described application of claim 8, described film-forming composition is used to make fresh-keeping film-coating.
11. application rights requires the hard-shell capsule of any described film-forming composition preparation of 1-7.
12. according to the production method of the described hard-shell capsule of claim 11, this method may further comprise the steps:
(1) claim 1-7 is any one film-forming composition and water are mixed into homogeneous latex emulsion, wherein the weight ratio of said composition is 10%～40%, with 100 ℃ of-170 ℃ of these emulsions of steam heating, place 50-90 ℃ of insulation then, obtain the film forming material of high-clarity;
(2) use automatic machine equipment and the above-mentioned film forming material of making hard gelatin capsule to make the hard rubber softgel shell.
13. according to the production method of the described hard-shell capsule of claim 12, this method may further comprise the steps:
(1) claim 1-7 is any one film-forming composition and water are mixed into homogeneous latex emulsion, wherein the weight ratio of said composition is 25～35%, with this emulsion of 125～140 ℃ steam heating, the time is 20-40 minute, places 24 hours 50-90 ℃ of insulation then;
(2) use automatic machine equipment and the above-mentioned film forming material of making hard or hard-shell capsule, make the hard rubber softgel shell according to the method for routine.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| EP2937081A1 (en) | 2014-04-21 | 2015-10-28 | Hunan Er-Kang Pharmaceutical Co., Ltd. | Hydroxypropyl starch vacant capsules and a process for producing them |
| US9693964B2 (en) | 2014-04-21 | 2017-07-04 | Hunan Er-Kang Pharmaceutical Co., Ltd. | Hydroxypropyl starch vacant capsules and a process for producing them |
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|---|---|
| CN101245157A (en) | 2008-08-20 |
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